QA Compliance Operations Lead/Coordinator - Hillerød, Capital Region of

Join a fast-scaling medicinal API site in Hillerød and become the trusted right hand to our QA Director and Compliance Officer. If you love turning strategy into action, connecting people and data, and keeping a site inspection-ready without the chaos—this is your role. You'll si ...

Jobbeskrivelse

Join a fast-scaling medicinal API site in Hillerød and become the trusted right hand to our QA Director and Compliance Officer. If you love turning strategy into action, connecting people and data, and keeping a site inspection-ready without the chaos—this is your role. You'll sit at the heart of QA, shaping decisions, enabling smooth audits and inspections, and driving focused improvements that make a visible difference to quality and flow on the shop floor.

About The Role
You'll represent the QA Director in key forums, coordinate readiness for audits and inspections, and lead small, high‑impact initiatives that keep our operations compliant and reliable. Depending on your background, experience, and interests, you'll have the opportunity to shape the role so we can succeed together. This role will be a great opportunity for a senior QA profile that would like to broaden their scope.

What you'll do

• Represent the QA Director in selected forums, building a strong internal network across Production, QC, Engineering, and MSAT. Gather insights, communicate priorities, and follow up on actions.
• Prepare decision-grade materials: collect data, create presentations and summaries for quality governance (QMR inputs, management updates, site reviews), and consolidate risks, actions, and outcomes.
• Drive audit and inspection readiness by coordinating pre-readiness checks, logistics, documentation, storyboards, and stakeholder briefings.
• Coordinate internal QA training to harmonize standards and set direction for QA decisions.
• Own selected QA KPIs: track, visualize, and report performance; drive follow-ups and trend analysis for leadership.
• Strengthen governance: maintain the department risk register, decision logs, and traceability from decision to action and outcome.

What you bring

• BSc/MSc in Pharmacy, Chemistry, Biotechnology, Engineering, Quality Management, or similar.
• 6+ years in GMP-regulated pharma/biotech; API manufacturing experience is a strong plus.
• Hands-on QA/Compliance experience with audit/inspection support and small-scale project management across multiple stakeholders.
• Strong grounding in EU GMP Part II for APIs and ICH Q7; familiarity with ICH Q9, data integrity, and FDA/EMA expectations.
• Comfortable with MS Office, SharePoint/Teams, and KPI dashboards; eQMS/LMS experience (e.g., Veeva, TrackWise) is an advantage.
• Fluent in English.

Application
If you are interested and ready to take the next step, please upload your CV and cover letter at your earliest convenience. We will conduct interviews on a rolling basis.

Even if you don't meet all the criteria but believe you can contribute meaningfully to our team, we encourage you to apply. We encourage you to bring your full self to work every day, as we value everyone's unique talents, diversity, and strengths through mutual trust. So just be you

FUJIFILM Biotechnologies
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth. We also offer access to fitness and an attractive canteen.

FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world's most innovative biotech and biopharma companies reimagining healthcare's potential. We work across the entire lifecycle of our customers' products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another's passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

We offer the chance to be part of a global workplace where passion, drive, and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone, no matter their background or gender, has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative, and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefits package.

FUJIFILM Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via email, the internet, or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.